MAUDE Adverse Event Report: C. R. BARD, INC. BARD; STENT, URETERAL

Catalog Number 136406LT

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/02/2021

Event Type  malfunction  

Event Description

During cystoscopy of left ureteral stent placement, left 6fr whistle tip stent was removed and only half of stent was accounted for.Upon removal of cystoscope from ureter, the provider thought the remaining portion of ureteral stent was removed.Per hospital policy, an x-ray was taken for a retained foreign object post-procedure and prior to extubation.A ~3mm cylindrical piece was identified on x-ray.

• Brand Name: BARD
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 12908076
• MDR Text Key: 281512979
• Report Number: 12908076
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 136406LT
• Device Lot Number: REEU1929
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 9855 DA
• Patient Sex: Male
• Patient Weight: 25 KG
• Patient Race: White